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临床试验/CTRI/2025/12/098339
CTRI/2025/12/098339招募中4 期

Comparison of Two Prophylactic Norepinephrine Doses for Prevention of Post-Spinal Hypotension on Umbilical Artery and Vein Blood-Gas Parameters in Patients Undergoing Elective Caesarean Section: A Randomized Controlled Study

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
90
试验地点
1

研究概览

简要总结

Spinal anaesthesia is the preferred technique for an elective caesarean section as it decreases airway manipulation and other potential complications related to GA1. Hypotension is the most common complication of spinal anaesthesia during caesarean delivery. As it can have adverse effects on the mother as well as the foetus, timely management of post-spinal hypotension is extremely important. Although various methods have been tried to reduce the incidence, vasopressors remain the mainstay of management of post-spinal hypotension.

Most common vasopressors used are phenylephrine, ephedrine and norepinephrine. Phenylephrine causes decreased maternal heart rate and subsequent fall in cardiac output. Ephedrine causes maternal tachycardia and decreases fetal pH. Norepinephrine has emerged as an effective prophylactic vasopressor with a favourable balance between maintaining maternal blood pressure and minimizing reflex bradycardia. Norepinephrine has dual alpha and beta agonist activity maintaining maternal cardiac output.

Current evidence on noradrenaline use in obstetric anaesthesia focuses mainly on maternal hemodynamic outcomes (blood pressure, heart rate, incidence of hypotension).Foetal outcomes, particularly blood gas parameters, are underexplored.

Comparative data between different prophylactic dosages of noradrenaline and their impact on foetal physiology are lacking. Although there are abundant literature2 about norepinephrine infusion and bolus in caesarean section, but till recently no study has been done in Indian population comparing the effect of different doses of norepinephrine on Foetal blood gas parameters.

This study addresses this gap by providing data on umbilical cord blood gases following two distinct norepinephrine prophylaxis regimens, thereby offering new insight into fetal acid–base balance in the context of spinal anaesthesia for caesarean delivery. This study aims to compare norepinephrine 0.04mcg/kg/min, 0.08mcg/kg/min and a placebo on fetal blood gas parameters in Indian population.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Women aged 18–35 years, full-term pregnant, scheduled for elective caesarean section under spinal anaesthesia, and belonging to ASA class II.

排除标准

  • 未提供

研究者

申办方类型
Other []
责任方
Principal Investigator
主要研究者

Dr CH RAMA KRISHNA PRASAD

AIIMS BIBINAGAR

研究点 (1)

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